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NCT Number: NCT06949228

Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy (ALLY) II Trial

The study objective is to evaluate the safety and efficacy of Intra arterial (IA) Tenecteplase (TNK) as an adjunctive therapy in acute ischemic stroke (AIS) patients with large vessel occlusions (LVO) in the anterior circulation of Internal Carotid Artery (ICA), Middle Cerebral Arteries (M1 and M2) who achieve a reperfusion grade of Modified Treatment in Cerebral Ischemia Scale (mTICI) 2b or higher post-mechanical thrombectomy using Food and Drug Administration (FDA) approved devices.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

ProMedica Toledo Hospital

Toledo, Ohio, 43606, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-85
  • Anterior circulation ischemic stroke symptoms with confirmed occlusion (ICA, M1, or M2) on angiogram and mechanical thrombectomy initiated within 24 hours since last known well
  • Alberta Stroke Program Early CT Score (ASPECTS) Score ≥6 on baseline Non-contrast Head CT (NCCT)
  • Post-mechanical thrombectomy with ≤5 device passes and mTICI grade 2b or higher.
  • Ability to obtain signed informed consent prior to randomization from LAR or Subject

Exclusion criteria

  • Premorbid modified Rankin scale (mRS) score >1
  • Imaging evidence of hemorrhage or mass effect at baseline
  • Platelet count <100,000
  • Active hemorrhagic diathesis, or known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
  • Active anticoagulation treatment with novel oral anticoagulant (NOACs) taken within the last 48 hours, or INR >1.7
  • Patients requiring active treatment with dual antiplatelet agents (e.g. proximal cervical carotid artery stenting)
  • Pregnant or lactating
  • Previous known allergy to TNK
  • Major surgery in past 30 days
  • Patient is on or requires dialysis
  • History of intracranial hemorrhage or serious head trauma at any time
  • Any condition in the opinion of the enrolling physician that would preclude the patient from participating
  • Pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluation
  • Severe, uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) that is refractory to treatment
  • History of acute ischemic stroke in the last 60 days and/or has received previous treatment with a thrombolytic within the last 90 days
  • Presumed septic embolus; suspicion of bacterial endocarditis
  • Suspicion of aortic dissection
  • Intracranial neoplasm
  • Any terminal medical condition with life expectancy less than 6 months
  • Concurrent enrollment in another trial that could confound the results of this study
  • Patient is unlikely to return for 90-day follow-up.
  • Intravenous tissue plasminogen activator (tPA) administered concurrently with Intra-arterial TNK

Treatment and study plan

Tenecteplase

Drug

Patients treated with standard of care mechanical thrombectomy (MT) that achieved mTICI 2b or higher revascularization. Patients will be randomized into one of two arms: IA TNK or control.

Primary outcomes

  1. Primary Efficacy Endpoint- Modified Rankin Scale (mRS)

    Time frame: 90 days (+/- 30 days) post treatment.

    Proportion of patients with Modified Rankin Scale (mRS) 0-1 at 90-days. The mRS is the standard tool to assess neurological outcome in trials with acute severe brain disease. The scale runs from 0-6, running from perfect health without symptoms (= 0) to death (= 6).

  2. Primary Safety Endpoint- Incidence of Intracranial hemorrhage and Neurologic Worsening

    Time frame: 24 hours (+/-12 hours) post treatment.

    Incidence of any intracranial hemorrhage and neurologic worsening of at least 4 points on the National Institute of Health Stroke Scale (NIHSS) associated with a Parenchymal hematoma, Type 2 (PH2) brain hemorrhage, according to the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST) criteria, within 24 (±12) hours from randomization.

Secondary outcomes

  1. Ordinal Modified Rankin Scale (mRS)

    Time frame: 90 days (+/-30 days) post treatment.

    Ordinal mRS at 90 day. The mRS is the standard tool to assess neurological outcome in trials with acute severe brain disease. The scale runs from 0-6, running from perfect health without symptoms (= 0) to death (= 6).

  2. Functional Independence

    Time frame: 90 days (+/- 30 days) post treatment.

    Proportion of patients with functional independence, defined as a mRS of 0-2 at 90 days.

  3. Final Revascularization Grade

    Time frame: Immediate post treatment.

    Final revascularization grade at end of IA treatment among those with less than mTICI 3 prior to IA-TNK administration.

  4. Mortality rate at 90 days

    Time frame: Mortality rate at 90-days (+/- 30 days) post treatment.

    Mortality rate at 90-days

  5. Mortality Rate at discharge

    Time frame: Day 6 (+/-1 day) or Discharge post treatment.

    Mortality rate at discharge.

  6. Infarct Volume Post Procedure

    Time frame: 24 hours (+/- 12 hours) post treatment.

    Infarct volume on post-procedure follow-up scans performed at 24 ± 12 hours following mechanical thrombectomy.

  7. Asymptomatic Intracranial hemorrhage

    Time frame: 24 hours (+/- 12 hours) post treatment.

    Incidence of any asymptomatic intracranial hemorrhage

  8. Mean Number of Boluses

    Time frame: Immediate post procedure.

    Mean number of boluses to achieve improvement in reperfusion to mTICI 2c and mTICI 3 among those without mTICI3 prior to IA-TNK administration.

Study contacts

Contact information is provided by the study sponsor or research team.

Syed Fazal Zaidi, MD

CONTACT

[email protected]

(419)- 291-8027

Tanya Siddiqui

CONTACT

4192913498

Sponsors and collaborators

Lead sponsor

ProMedica Health System

Other

Registry information

Acronym: ALLY II TNK

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 29, 2025
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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